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Trial record 17 of 532 for:    VANCOMYCIN

Vancomycin Pharmacokinetics in Patients on Peritoneal Dialysis

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ClinicalTrials.gov Identifier: NCT03685747
Recruitment Status : Recruiting
First Posted : September 26, 2018
Last Update Posted : September 12, 2019
Sponsor:
Information provided by (Responsible Party):
Walter K. Kraft, Thomas Jefferson University

Tracking Information
First Submitted Date  ICMJE September 25, 2018
First Posted Date  ICMJE September 26, 2018
Last Update Posted Date September 12, 2019
Actual Study Start Date  ICMJE November 15, 2018
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 25, 2018)
  • Maximum total plasma concentration (Cmax) [ Time Frame: Day: 1 ]
    Total systemic plasma concentration following 12-hour dwell
  • Time to maximum plasma concentration (Tmax) [ Time Frame: Day: 1 ]
    Time (hours) to achieve the maximum plasma concentration
  • Area under the concentration-time curve (AUC0-T) [ Time Frame: Days: 1-7 ]
    AUC based on vancomycin plasma concentrations
  • Total body clearance (CLtotal) [ Time Frame: Days: 1-7 ]
    Total vancomycin plasma vancomycin clearance
  • Dialytic Clearance [ Time Frame: Days: 1-7 ]
    Vancomycin clearance from peritoneal dialysis
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03685747 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 25, 2018)
Adverse events [ Time Frame: Days: 1-7 ]
Any adverse events throughout entirety of study as assessed by physician-investigator
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vancomycin Pharmacokinetics in Patients on Peritoneal Dialysis
Official Title  ICMJE A Prospective, Single-site, Open-label, Pharmacokinetic Study of Intermittent Intraperitoneal Vancomycin in Adult Subjects Receiving Automated Peritoneal Dialysis
Brief Summary Vancomycin is the most commonly used empiric treatment for infectious peritonitis in patients on peritoneal dialysis. Current dosing and monitoring for safety and efficacy is empiric, especially for those on rapid-cycling modalities. The goal of this study is to understand the pharmacokinetics of vancomycin in patients on rapid-cycling peritoneal dialysis modalities in order to derive an optimal dosing regimen.
Detailed Description

Peritoneal dialysis (PD) is a form of renal replacement therapy indicated for those with acute kidney injury or end stage renal disease. Currently, two modalities of PD exist and is individualized based on patient and life-style specific factors. Continuous ambulatory peritoneal dialysis (CAPD) allows 4 - 5 exchanges performed manually whereas automated peritoneal dialysis (APD) involves continuous, automated, cyclical exchanges performed by a device at home during the night. Peritonitis is a common complication in PD and accounts for a large portion of hospital readmission and mortality. Vancomycin is the most common antibiotic recommended and has notable gram-positive coverage used empirically during suspected peritonitis.

Despite widespread use, vancomycin lacks good pharmacokinetic characterization in PD. Early pharmacokinetic studies using vancomycin were conducted predominantly in patients on CAPD on glucose-based prescriptions. Data is non-existent in PD patients administered the novel dialysate solution icodextrin, or those treated with overnight APD. The impact of residual kidney function (RKF) on vancomycin in PD is also lacking. Enhanced vancomycin clearance in RKF may result in under-dosing, while overdosing may result in nephrotoxicity and loss of clinically important RKF.

The investigators will characterize the pharmacokinetic profile of vancomycin following a single intraperitoneal dose of vancomycin in icodextrin dialysate to non-infected PD patients and examine the relationship between RKF and vancomycin clearance using serum, dialysate and urine. The goal is to use this data in non-infected subjects to generate information to guide vancomycin dosing in patients on rapid-cycling PD modalities.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Peritoneal Dialysis-associated Peritonitis
Intervention  ICMJE Drug: Vancomycin
Vancomycin one-time 20 mg/kg intraperitoneal dose.
Study Arms  ICMJE Experimental: Vancomycin
A single 20 mg/kg intraperitoneal dose in 1-liter of 7.5% icodextrin solution of vancomycin will be administered. Sparse blood sampling will be obtained during an overnight 12-hour dwell and during the exchange period.
Intervention: Drug: Vancomycin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 25, 2018)
4
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2020
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adult male or females between 18 - 85 years old
  • Stabilized on a PD regimen for > 3 months prior to study initiation

Exclusion Criteria:

  • Clinically significant disease unrelated to renal impairment or deemed unfit by the investigator
  • Allergy or hypersensitivity to vancomycin or icodextrin-containing dialysis solution
  • Active peritonitis infection
  • Previous intraperitoneal antibiotic treatment within 2 months
  • Previous intravenous vancomycin treatment within 2 months
  • Hemoglobin < 9 g/dL
  • Pregnant or breast-feeding women
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Edwin Lam, PharmD 215-955-9076 edwin.lam@jefferson.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03685747
Other Study ID Numbers  ICMJE 12451
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Walter K. Kraft, Thomas Jefferson University
Study Sponsor  ICMJE Thomas Jefferson University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Walter K Kraft, MD Thomas Jefferson University
PRS Account Thomas Jefferson University
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP